1
Analyze the Remaining Gaps as Data Exchange is Expanded
to Broader Stakeholder Groups in Support of Innovation
Session INT3, February 11, 2019
Steven Lane, MD, MPH, FAAFP
Clinical Informatics Director - Privacy, Information Security & Interoperability, Sutter Health
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Steven Lane, MD, MPH, FAAFP has no conflicts of interest to
report
Conflict of Interest
3
The push for advancing interoperability and increased demand
for health information exchange has given rise to expanding
stakeholder groups
This has exposed a variety of gaps in data exchange
In this session, we will identify and explore what gaps exist and
discuss innovative ways in which data is being exchanged to
help diminish these gaps
Presentation Purpose
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1. Identify barriers in data reciprocity and data exchange when it
comes to expanding stakeholder groups
2. Recognize the impact of stakeholder gaps in regards to patient
and value-based care
3. Describe innovative ways in which some stakeholders are
addressing disparities in data exchange
Learning Objectives
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Background
Current State
Stakeholders
Gaps
Federal support
Innovations
Conclusions
Outline
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Definitions
Degrees of Interoperability
Benefits
Background
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“The term ‘interoperability’, with respect to health information
technology, means health information technology that
a. enables the secure exchange of electronic health information
with, and use of electronic health information from, other health
information technology without special effort on the part of the
user
b. allows for complete access, exchange, and use of
all electronically accessible health information for
authorized use under applicable State or Federal law
c. does not constitute information blocking as defined in section
3022(a) of the Public Health Service Act as amended
21
st
Century Cures Act
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Interoperability is the ability of different information systems,
devices or applications to connect, in a coordinated manner,
within and across organizational boundaries to access, exchange
and cooperatively use data amongst stakeholders, with the goal of
optimizing the health of individuals and populations
HIMSS, Defining Interoperability in the Health Ecosystem
Available for public comment until March 23, 2019
https://www.himss.org/library/interoperability-standards/what-is-interoperability
HIMSS
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Technical
Foundational connectivity
Syntactic Data Liquidity
Common data formatting
Maintain field level interpretation
Semantic Data Portability
Codified data mapped to standard vocabularies
Maintain meaning
Functional Data Utility
Integration into local workflows, clinical, and analytical processes
Degrees of Interoperability
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Triple Aim
Value Quality / Cost
Health individual, population
Satisfaction / experience patient, provider, care team
Impact on care
Direct patient care
Population health management
Value based care: Alignment of incentives > exchange
Patient safety
250,000 deaths / year due to preventable medical errors
Benefits of Interoperability
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Background
Current State
Stakeholders
Gaps
Federal support
Innovations
Conclusions
Outline
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Interoperability Methodologies
Connectivity Landscape
Evolving Capabilities
Metrics
Current State
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Telephone, postal mail, FAX
Secure file transfer
HL7 Version 2 interfaces PUSH
Within and between institutions
Focused use cases: Orders/results, ADT, registry reporting
Document Exchange PUSH & PULL
Clinical Document Architecture (CDA) HL7 Version 3
Consolidated CDA (C-CDA) 12 document types, 70 sections
Fast Healthcare Interoperability Resources (FHIR
®
) – PULL > PUSH
Modular data element exchange
Supports Application Programming Interfaces (APIs)
Interoperability Methodologies
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Health Information Exchanges (HIEs)
Centralized data stores +/- value added services
Regional and use-specific (e.g., payers, research)
Direct Interoperability
DirectTrust
Health Information Service Providers (HISPs)
National networks
eHealth Exchange
Single and multi-vendor networks
Exchange frameworks Connect networks
Carequality
Trusted Exchange Framework & Common Agreement (TEFCA)
Connectivity Landscape
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Evolving Capabilities
Traditional
Point-to-point
connections
HL7 V2 interfaces
Individual and
community trust
agreements
ADT feeds to central
repositories (HIEs)
Ad hoc CDA
document query, push
Individual access:
portal, PDF
Transitional
HIPAA/HITAC, MU/PI
Transitions of Care
Treatment use cases
Federated
architecture and trust
Automated queries at
point of care
Patient summary CCD
Discrete PAMI data
Minimum necessary
challenges
Individual access:
VDT capability, CCD
Innovative
More:
Participants
Use cases
Discrete data
C-CDA templates
Automation
Pop health bulk
query
Patient Centered
Data Home
FHIR: Read > write
Individual access:
apps / APIs
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While there are, as yet, no accepted standards by which to measure
interoperability, there have been dramatic and progressive
increases in the volume of transactions and the types and utility of
data exchanged
Sources:
Office of the National Coordinator for Health Information
Technology (ONC) reports
American Hospital Association (AHA) surveys
Carequality document exchange metrics
DirectTrust transaction volume
Metrics
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ONC Measurement Framework
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2017 Data:
70% of hospitals participated in nationwide HIE networks
51% of hospitals had necessary patient data available
from outside of their systems at point of care
53% of those organizations able to integrate received
health data into their EHR
Small, rural, and critical access hospitals had lower rates of using
electronic methods to exchange summary of care records
compared to their counterparts
ONC
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Hospital Interoperability
AHA Survey
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Patient Access & Exchange
72% of hospitals have the capability for patients to electronically
view, download and transmit their health information
AHA Survey
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Carequality – Document Exchange
0
2,000,000
4,000,000
6,000,000
8,000,000
10,000,000
12,000,000
14,000,000
16,000,000
December 2016 - December 2018
Cumulative total = 114 M
~14M documents exchanged / mo.
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DirectTrust – Transactions
0
20,000,000
40,000,000
60,000,000
80,000,000
100,000,000
120,000,000
2014 2015 2016 2017 2018
110,253,902
Number of Send and Receive Direct Transactions
between Trusted Endpoints by Quarter
~37M Transactions / month
Cumulative total = 607 M
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Background
Current State
Stakeholders
Gaps
Federal support
Innovations
Conclusions
Outline
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Stakeholders Identified in TEFCA-1
PROVIDERS
Professional care providers who
deliver care across the continuum, not
limited to but including ambulatory,
inpatient, long-term and post-acute
care (LTPAC), emergency medical
services (EMS), behavioral health, and
home and community based services
INDIVIDUALS
Patients, caregivers,
authorized representatives,
and family members serving in
a non-professional role
FEDERAL AGENCIES
Federal, state, tribal, and
local governments
TECHNOLOGY DEVELOPERS
Organizations that provide health IT capabilities,
including but not limited to electronic health
records, health information exchange (HIE)
technology, analytics products, laboratory
information systems, personal health records,
Qualified Clinical Data Registries (QCDRs),
registries, pharmacy systems, mobile
technology, and other technology that provides
health IT capabilities and services
PAY ERS
Private payers, employers, and
public payers that pay for
programs like Medicare,
Medicaid, and TRICARE
PUBLIC HEALTH
Public and private organizations and agencies
working collectively to prevent, promote and
protect the health of communities by
supporting efforts around essential public
health services
HEALTH INFORMATION NETWORKS
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Public Health
Surveillance and reporting
Clinical services: health centers, dental, nursing, EMS,
disaster services, shelters, outreach, environmental
Coroners
Federal / Government Agencies
Clinical services:
Corrections, DoD/DHA, Indian Health Serv., Schools, VA
Research / administration:
AHRQ, CDC, DoC, HHS, HRSA, NIH, NLM, ONC
Law enforcement
More than meets the eye
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Small, rural and critical access hospitals and clinics
Pediatrics Excluded from Meaningful Use incentive program
Telehealth
Non-physicians Dentistry, Optometry, Audiology, Podiatry
Therapies Physical, Occupational, Speech, etc.*
Behavioral Health *
Substance abuse treatment
DME
EMS
LTPAC
Home health
Complementary care Naturopaths, chiropractors, acupuncturists, homeopaths, etc.
* Included in 2019 Quality Payment Program
Providers with limited connectivity
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Research
Public, private, academic, networks
Pharmacy
Retail pharmacies
Pharmacy Benefit Management
Pharma companies e.g., post marketing surveillance
Insurance
Life
Disability
Casualty
Additional Stakeholders
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Background
Current State
Stakeholders
Gaps
Federal support
Innovations
Conclusions
Outline
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Evolving/competing standards
Data Utility
Other Barriers
Gaps
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Governance – Varies by technology, network, HIO
Security and trust Varies by technology, network, push vs. pull
Format and transport
HL7 V2, C-CDA, FHIR Which to use?
Content
Data – SDOs, Information modeling initiatives
Common Clinical Data Set Evolving 2014 > 2015 CEHRT standard
US Core Data for Interoperability (USCDI) glide path – 2019 and beyond
C-CDA templates
FHIR Argonaut profiles, US Core
Privacy
Varies by state, data type
Personal data beyond HIPAA covered entities??
Multitude of Standards
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Access / view
Ingest
Interpret
Integrate / reconcile
Incorporate into standard workflows
#WithoutSpecialEffort
Data Utility
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Economic barriers
Business models and practices
Information Blocking Pending final rulemaking
Inefficiency
System design
Procurement
Implementation
Integration
Support
- Procuring Interoperability: Achieving High-Quality,
Connected and Person-Centered Care, Washington, DC: 2018
Other Barriers
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Background
Current State
Stakeholders
Gaps
Federal support
Innovations
Conclusions
Outline
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EHR certification program 2015 Edition requiring patient API access
Interoperability Standards Advisory
Interoperability Proving Ground Implementations
Tech Lab Standards Coordination
DRAFT US Core Data for Interoperability (USCDI)
DRAFT Trusted Exchange Framework & Common Agreement
PENDING proposed Information Blocking clarifications
OCR RFI regarding potential changes to HIPAA to improve information
sharing for treatment and care coordination
HHS/ONC Support for Interoperability
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Meaningful Use > “Promoting Interoperability
MyHealthEData
Blue Button 2.0
Beneficiary access to CMS claims data via FHIR APIs
Required use of 2015 Certified EHR Technology (CEHRT)
Includes patient data access via APIs, exchange of the Common Clinical
Data Set, Patient-directed exchange
Performance Measures
Include electronic referral loops, clinical information reconciliation, real
time drug formulary and PDMP queries
Proposals
Require interoperability as Medicare Condition of Participation
Require Medicare Advantage plans to provide Blue Button 2.0 capabilities
CMS Support for Interoperability
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Background
Current State
Stakeholders
Gaps
Federal support
Innovations
Conclusions
Outline
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Direct
Consolidated Clinical Document Architecture (C-CDA)
Fast Healthcare Interoperability Resources (FHIR
®
)
Provider-Payer data exchange
Consumer-mediated exchange
…PLUS MANY MORE!
Innovations to close the gaps
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Broadly implemented to support Transitions of Care (ToC) as required by
Meaningful Use Stage 2
Successfully implemented innovative use cases:
Query and push based on ADT events
Current CCD requested by & sent to ED upon patient arrival
Care team notifications at time of hospital/ED discharge
To PCP, care manager, home care team
Results delivery without point-to-point interfaces
Care coordination messaging between care team members
Closed loop referrals – Now required by CMS
Cross-organization, cross-vendor
Fax > Direct conversion improved security, integration
https://www.directtrust.org/wp-content/uploads/2018/11/Master-List-of-Direct-Interoperability-Success-Stories.pdf
Direct - Beyond ToC
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Leverages established technical interoperability standards to
facilitate closed loop ambulatory referrals via Direct
Supports the exchange of clinical and scheduling
information between providers
Successfully tested across multiple EHR vendors
Being demoed in the HIMSS Interoperability Showcase
Future focus:
Acute to LTPAC transfers
Insurance pre-authorization
360X
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Clinicians identified challenges related CCD quality and usability:
Unacceptably large documents
Lack of clinical notes
Desire for encounter-specific documents in addition to
patient summary documents
Need for document version management
Carequality-CommonWell Joint Document Content Workgroup
Improving C-CDA Exchange
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Workgroup Recommendations:
Implementers shall support encounter-specific documents utilizing
specific C-CDA document templates:
Progress Note Document Outpatient encounters
Discharge Summary Document Inpatient encounters
Limit data included in encounter documents to:
Information generated at the time of the encounter
Patient level data, e.g., Problems, Medications, Allergies,
reviewed / validated during encounter
Respect time parameters for encounter document queries
Supports a consolidated longitudinal view of patient records
including encounters from multiple institutions and vendors
Improving C-CDA Exchange
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Release 1
1. Consultation Note
2. Continuity of Care Document (CCD)
3. Diagnostic Imaging Report
4. Discharge Summary
5. History and Physical
6. Operative Note
7. Procedure Note
8. Progress Note
9. Unstructured Document
Content Testing Program
Release 2
10. Care Plan
11. Referral Note
12. Transfer Summary
C-CDA Document Types
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Implementing Direct messaging
Improvements to CCD section contents
C-CCD Data Quality Initiative
Analyze received documents for completeness, quality,
adherence to standards
PAMI data, procedures, vitals
Focus on critical data access and patient safety
White Paper: Interoperability Progress and Remaining Data
Quality Barriers of Certified Health Information Technologies
https://www.intersystems.com/isc-resources/wp-content/uploads/sites/24/Interoperability_Progress_
Remaining_Data_Quality_Barriers_Certified_Health_Information_Technologies.pdf
VA Innovations
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Release 4 Published January 2, 2019
Normative standard:
RESTful API, XML and JSON formats
Terminology layer, conformance framework
Basic data types
Key Patient and Observation Resources
Future changes will be backward compatible
HL7
®
FHIR
®
®
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Heat Wave: The U.S. is Poised
to Catch FHIR in 2019
87% of hospitals, 57% of clinicians using EHRs certified to use FHIR Release 2
10/01/2018
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Use cases
Treatment
Case management acute, chronic
Care coordination
Healthcare Operations
Prior authorization
Quality reporting HEDIS, STARS
Formulary management
Payment
Utilization and appropriateness of care review
Risk adjustment HCC coding
Claims adjudication
Payer-Provider Data Exchange
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Policy issues
Minimum necessary requirements vary by use case
Self-pay restrictions
Release restrictions / confidential data
Re-purposing data
Payer-Provider Data Exchange
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Technology solutions
Central repositories
Manifest Medex (CA)
C-CDA exchange
Carequality
FHIR
®
ONC-led FAST Initiative Governance, policy
HL7 Da Vinci Project IGs, reference implementations
Vendor network solutions
Moxe Health
Epic Payer Exchange
Payer-Provider Data Exchange
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Da Vinci Project
Interoperability
Showcase:
9100-49
Leveraging FHIR
®
for payer-provider data exchange
High priority use cases to support value based care:
Quality Measure Collection
Clinical Data Exchange
Pre-order Burden Reduction
Health Record
Exchange:
Clinical Data
Exchange
Documentation
Templates and
Coverage
Rules
Gaps in Care &
Information
Coverage
Requirements
Discovery
Performing
Laboratory
Reporting
Data Exchange
for Quality
Measures
Prior-
Authorization
Support
Risk Based
Contract
Member
Identification
In HL7 ballot reconciliation as draft standard
Under active development
Planned 2019 Use Cases
Future Use Case
Alerts:
Notification (ADT),
Transitions in
Care, ER
admit/discharge,…
Patient Cost
Transparency
Chronic Illness
Documentation
for
Risk Adjustment
Health Record
Exchange:
Payer Data
Exchange
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Consumer-Directed Exchange in
an Evolving App Ecosystem
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NewWave Telecom & Technologies
MyCareAI app Standards-based, consumer-controlled health
data convergence hub”
Participating providers enroll Medicare beneficiaries
App requests claims history via Blue Button (FHIR)
Query for clinical data from providers based on claims
Aggregate and assemble longitudinal patient record
Evaluate quality metrics, identify risks for patient and population
Feedback to patient and providers (via regional health
information network)
Offer services
www.NewWave.io HIMSS Booth #509
Leveraging Blue Button 2.0
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SAFE Health
Initial focus on sexual health, STD testing, and treatment
Integrate with Dating Apps to incentivize regular testing and
sharing of sexual health status
Home-grown EHR + interoperability
Labs for testing > historical data access (FHIR)
Pharmacies for e-prescribing & delivery (HL7 V2)
EHRs via Carequality for bidirectional exchange (C-CDA)
Developing to the Apple Health API (FHIR)
www.SafeHealth.me
Telehealth Integration
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Beta launch - January 24, 2018
1/16/2019: 167 healthcare organizations offering FHIR API-based
access to data from 3 EHR vendors AthenaHealth, Cerner, Epic
LabCorp and Quest lab data access / integration
Recent user survey: 90% of users endorsed:
“The smartphone solution improved their understanding of their
own health, facilitated conversations with their clinicians, or
improved sharing of personal health information with friends
and family.”
Dameff C, Clay B, Longhurst CA. Personal Health Records:
More Promising in the Smartphone Era? JAMA. 2019;321(4):339-340.
Apple Health Records
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Patient-facing:
Service Providers:
Telehealth
Care plans,
patient monitoring
Apps using Health Records data
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Source: https://support.apple.com/en-us/HT208647; as of 01/16/2019
Apple Health Records Market Penetration
Number of hospitals by Zip Code live with Apple FHIR API access
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Patient access to EHR data via APIs
0M
73M
117M
118M
134M
151M
162M
181M
182M
188M
191M
197M
0
50
100
150
200
250
Jan.
'18
Feb. Apr. May Jun. Jul. Aug. Sept. Oct. Nov. Dec. Jan.
'19
Millions
Source: https://torchinsight.com/
Individuals with potential access to the common clinical data set
information in their EHR(s) via API access
vs. ~80M US iPhone users
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Background
Current State
Stakeholders
Gaps
Federal support
Improvement / innovation efforts
Conclusions
Outline
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WE HAVE:
Stakeholder engagement
Mature standards must continue to evolve
Increasing Connectivity varies across users, technologies
Trust frameworks
Federal DURSA eHealth Exchange
DirectTrust
Carequality
SHIEC
NATE
Government support
HIT investment $9.5B in 2018!
Interoperability is within our reach!
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WE NEED:
Interoperability by design
Vendor development and user implementation to:
Automate exchange
Integrate data in workflows
Extend APIs beyond patient access and use
Continued evolution of standards: C-CDA, FHIR, Argonaut profiles
Clarification and enforcement of Information Blocking rules
Finalize and implement a comprehensive TEFCA
Implement the proposed USCDI glide path
“Omics” data Device data
PGHD SDoH
To #KillTheFax
Interoperability is within our reach!
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With CommonWell and Carequality linked, the biggest technical
obstacle to widespread patient-record sharing has been removed
The healthcare industry is rapidly approaching the point where an
organization using any of the major acute care/ambulatory EMRs
should be able to easily connect to other provider organizations
with minimal cost and effort
Today, the biggest barriers preventing widespread participation
are governance and the need for organizations to decide to
participate
KLAS – Interoperability 2018
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HHS / ONC Federal Advisory Committees Work Groups and Task Forces
https://www.healthit.gov/topic/federal-advisory-committees/membership-
application
ONC FHIR at Scale Taskforce (FAST) Tiger Teams
https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Tiger+Teams
The Sequoia Project Interoperability Matters Workgroups
https://sequoiaproject.org/interoperability-matters/
Carequality Advisory Committee, Workgroups
https://carequality.org/get-involved/
DirectTrust Task forces
https://www.directtrust.org/
Opportunities for Participation
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Contact information:
LaneS@SutterHealth.org
@emrdoc1
www.linkedin.com/in/steven-lane-md/
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